Knot setter

ABSTRACT

A surgical knot setter includes an elongated shaft having a long axis and proximal and distal portions. A tip is provided at the distal end of the shaft. The tip has a loop with an interior loop opening and a gate opening for permitting ingress and egress of a suture into the loop opening. The loop is laterally offset from the long axis and distal to the distal end of the shaft, such that the loop is laterally and longitudinally offset from the distal end of the shaft. A closure is provided for selectively opening and closing the gate opening between open and closed positions to selectively permit or prevent the suture from passing through the gate opening. An actuator moves the closure between the open and closed positions. A method for tying suture knots is also disclosed.

BACKGROUND OF THE INVENTION

The tying of suture knots is a time consuming and tedious part of thesurgical process. Multiple knots must be tied to place a suture,sometimes four or more knots per suture, and multiple sutures, sometimesnumbering in the hundreds, must be tied during some surgeries. Variousdevices have been used to assist the surgeon in sitting the surgicalknots.

SUMMARY OF THE INVENTION

A surgical knot setter has an elongated shaft having a long axis andproximal and distal portions and a tip at the distal portion of theshaft. The tip has a loop with an interior loop opening and a gateopening for permitting ingress and egress of a suture into the loopopening. The loop is laterally offset from the long axis of the shaftand distal to the distal end of the shaft, whereby the loop is laterallyand longitudinally offset from the distal end of the shaft. A closure isprovided for selectively opening and closing the gate opening betweenopen and closed positions to selectively permit or prevent the suturefrom passing through the gate opening. An actuator moves the closurebetween the open and closed positions.

A handle is provided at the proximal end of the shaft. A portion of theactuator is provided in the handle. A portion of the actuator can bealigned with the loop and with the shaft. The shaft can be cylindrical.

The closure can be pivotally connected to the tip and operation of theactuator can cause pivoting of the closure between open and closedpositions. The closure can be pivotally mounted to an exterior portionof the tip. The tip can have an interior channel and the closure can bepivotally mounted within the channel.

The tip can have a guide surface for directing the suture into the gateopening. The guide surface can extends from a side of the shaft to theloop.

Biasing can be provided for biasing the closure to the closed position.A portion of the actuator can operate against the biasing to move theclosure to the open position.

The elongated shaft can be hollow and can have a drive shaft within theelongated shaft. The elongated shaft can be connected to the closure andto a crank, such that rotation of the crank rotates the drive shaft andthe closure. A spiral groove can be provided in the crank and a pin inthe groove. The pin is connected to a trigger, such that movement of thetrigger moves the pin to contact the spiral groove and rotate the crankand drive shaft.

A method for tying knots with sutures, includes the steps of: providinga surgical knot setter, comprising an elongated shaft having a long axisand proximal and distal portions; a tip at the distal end of the shaft,the tip having a loop having an interior loop opening and a gate openingfor permitting ingress and egress of a suture into the loop opening, theloop being laterally offset from the long axis and distal to the distalend of said shaft, whereby the loop is laterally and longitudinallyoffset from the distal end of the shaft; a closure for selectivelyopening and closing the gate opening between open and closed positionsto selectively permit or prevent the suture from passing through thegate opening; and an actuator for moving the closure between the openand closed positions; positioning the actuator to cause the closure tomove to the open position; moving a suture through the gate opening intothe interior opening of the loop; operating the actuator to cause theclosure to move to the closed position; tying the suture knot and movingthe loop to set the suture knot in position; operating the actuator tomove the closure to the open position; and, removing the loop from thesuture by passing the suture through the gate opening.

BRIEF DESCRIPTION OF THE DRAWINGS

There is shown in the drawings embodiments which are presentlypreferred, it being understood, however, that the invention can beembodied in other forms without departing from the spirit or essentialattributes thereof.

FIG. 1 is a perspective view, partially in phantom, of a knot setteraccording to the invention.

FIG. 2 is side elevation, partially in phantom.

FIG. 3 is a front elevation.

FIG. 4 is a side view of a tip portion.

FIG. 5 is a top plan view of a tip portion.

FIG. 6 is a cross section of a knot setter according to the invention.

FIG. 7 is an enlarged cross section of a proximal portion of a knotsetter.

FIG. 8 is a perspective view of an actuator assembly.

FIG. 9 is an exploded perspective view of an actuator assembly,partially in phantom.

FIGS. 10 (A)-(C) are respectively a perspective view of a proximalportion (10A), a cross section of the proximal portion (10B), and aperspective view of a distal tip portion (10A), showing the actuator andtip assembly in a first mode of operation.

FIGS. 11(A)-(C) are respectively a perspective view of a proximalportion (11A), a cross section of the proximal portion (11B), and aperspective view of a distal tip portion (11C), showing the actuator andtip assembly in a second mode of operation.

FIGS. 12(A)-(D) are side elevations of a distal tip portion illustratinga method of placing a suture knot according to the invention.

FIG. 13 is a top plan view, partially in phantom, illustrating a tipportion.

FIG. 14 is a perspective view of a tip portion, partially in phantom, ina first mode of operation.

FIG. 15 is a perspective view of a tip portion, partially in phantom, ina second mode of operation.

FIG. 16 is a perspective view of an alternative closure and drive shaftdesign.

FIG. 17 is a perspective view of an alternative drive shaft.

FIG. 18 is a front elevation of an alternative closure.

FIG. 19 is a cross section of a tip having the alternative closure anddrive shaft.

DETAILED DESCRIPTION OF THE INVENTION

There is shown in FIGS. 1-15 a knot setter 20 according to theinvention. The knot setter 20 has an elongated shaft 24 having a longaxis 28 and proximal end 32 and distal end 36. A tip portion 40 isprovided at the distal end 36 of the shaft 24. The tip 40 has a loop 44defining an interior loop opening 48 and a gate opening 52 permittingingress and egress of a suture into the loop opening 48. The loop 44 islaterally offset from the long axis 28 of the elongated shaft 24, and islongitudinally distanced from the distal end 36 such that the loop 44 islaterally and longitudinally offset from the distal end 36 of theelongated shaft 24. The loop 44 can have any shape or size suitable forretaining the suture, but sharp edges which could damage tissue or cutthe suture should be avoided. A closure 56 is provided for selectivelyopening and closing the gate opening 52 between open and closedpositions to selectively permit or prevent the suture from passingthrough said gate opening 52. An actuator assembly 60 moves the closure56 between the open and closed positions. The closure 56 in oneembodiment remains in the closed position until the actuator assembly 60is manipulated to move the closure 56 to the open position, and isautomatically returned to the closed position when the actuator isreleased. The surgeon thereby does not have to manipulate the actuatorto close the loop around the suture or to retain the suture in the loop.

The actuator assembly 60 can include biasing which biases the closure 56to the closed position, such that the surgeon can tie multiple knotswhile the suture remains secure in the loop 44. The actuator assembly 60can include a spring 64 to bias the closure 56 to the closed position. Ahandle 68 can be provided and can be connected to the elongated shaft24. The handle 68 can be a single piece or can comprise multiple piecessuch as proximal piece 69 and distal piece 73, which can be securedtogether by suitable connecting structure such as cooperating threads75. The elongated shaft 24 can have an open interior through whichextends a drive shaft 72. The drive shaft 72 can be secured to a crank76 as by a set screw 78. The crank 76 can be rotatably mounted in aninterior opening 74 of the handle 68. The crank 76 can have a spiralgroove 80 formed in an outer surface 84 thereof and extendinglongitudinally and radially around the surface 84. A pin 88 is fixed tothe underside of a trigger 92. The trigger 92 is slidably mounted in aslot 96 formed in the handle 68 and opening to the exterior from theinterior opening 74. The pin 88 extends into the groove 80 on the crank76. Movement of the trigger 92 within the slot 96 will cause the pin 88to move through the groove 80, and as the pin 88 strikes the sides ofthe spiral groove 80 the pin 88 will cause rotation of the crank 76.Rotation of the crank 76 will cause rotation of the drive shaft 72. Thedrive shaft 72 at a distal end thereof is connected to the closure 56,so that rotation of the drive shaft 72 will cause rotation of theclosure 56 between the open and the closed positions.

The spring 64 can be positioned in a spring seat 100 provided in theinterior opening 74 of the handle 68, and can act on a spring slide 104that is slidably mounted on the drive shaft 72 and acts on the crank 76to bias the crank 76 and trigger 92 forward, and thereby the drive shaft72 and closure 56 to the closed position. In this manner the physiciandoes not have to maintain pressure on the trigger 92 in order to retainthe suture in the loop opening 48 of the loop 44. Other constructionsfor opening and closing the closure 56 and for biasing the closure 56are also possible. A cable or other structure can take the place ofcrank shaft 72. Motorized or electrically operated actuators for theclosure 56 are also possible. Operation of the trigger 92 causesmovement of the closure from the closed position (FIGS. 10A-C) to theopen position (FIG. 11A-C).

In one configuration, the center of the loop 44 is laterally offset fromthe longitudinal axis 28 of the elongated shaft 24 a distance “a” (FIG.5). In one embodiment, the distance “a” exceeds the radius of the shaft24. In another embodiment, the center of the loop 44 is offset by adistance “a” that exceeds the diameter of the shaft 24. The loop 44 canbe longitudinally spaced from the distal end 36 of the shaft 24 adistance “b” (FIG. 5). The distance “b” is preferably greater than thediameter of the shaft 24. The trigger 92 can be angularly aligned withthe loop 44 so that the surgeon has knowledge of the position of theloop 44 even when it is obscured from view by knowing only the angularposition of the trigger 92. Other structure can be provided on the shaft24 or the handle 68 and angularly aligned with the loop 44 to assist indetermining the angular position of the loop 44.

The elongated shaft 24 can have varying lengths and diameters. It ispossible to provide different sizes of knot setters according to theinvention for different surgical settings where different lengths andconfigurations of the shaft 24, tip 40 and loop 44 are desirable. Theelongated shaft 24 should be smooth at least in areas prone to touch thesuture so as to avoid cutting or abrading the suture. The shaft 24 canbe cylindrical in shape for this purpose. The tip 40 is configured suchthat there is a smooth sliding surface 110 leading to the loop opening48, so that the suture will be directed into the loop opening 48 whenthe tip 40 is moved gently against the suture and the closure 56 is inthe open position.

Different configurations of the tip 40 are possible. In theconfiguration shown the closure 56 can extend through a slot 116 formedin the tip to close the loop 44 (FIG. 14). The closure 56 is movedthrough the slot 116 to open the loop 44. The closure 56 is returned tothe closed position by operation of the actuator, such as by releasingof the trigger 92 to permit the spring 64 to act on the crank 76 andthereby the drive shaft 72 to move the closure 56 through the slot 116and close the loop 44 (FIG. 15). In another configuration the closure ispositioned adjacent to the tip on a distal side of the tip 40, and isnot positioned in a slot. The closure in this embodiment has a concavesurface which mates with a convex distal surface on the tip 40 to permitrelative pivoting. This is necessary given the angle between the crankshaft 72 and the closure 56.

The knot setter of the invention can be made from a variety of differentmaterials, such as surgical grade stainless steels and plastics. Bariumsulfate or other radio opaque material can be applied to or incorporatedinto these materials in order that the materials can be preciselylocated in the body.

Operation of the knot setter is shown in FIGS. 12 (A)-(D). The tip 40 ofthe knot setter 20 is positioned adjacent a suture 114 (FIG. 12A). Theclosure 56 is moved to the open position by operation of the trigger 92.The loop 44 is placed adjacent to the suture 114, and the position ofthe trigger 92 can be used to determine the position of the loop 44 ifit cannot be seen. The guide surface 110 assists in guiding the sutureinto the opening 48 of the loop 44 (FIG. 12B). The trigger 92 is thenreleased to permit the closure 56 to move to the closed position underthe bias of spring 64. A knot 118 is then tied (FIG. 12C). The knot 118can then be pushed into the body or “set”, and the closure 56 is openedsuch that the loop 44 can be removed from around the suture 114 and theknot setter 20 can be removed from the patient's body (FIG. 12D).

FIGS. 16-19 illustrate an alternative embodiment in which an elongatedshaft 118 encloses a drive shaft 120. The drive shaft 120 has aprotrusion 124 for engaging the closure 136. The closure 136 has arectangular opening 140 that can be a square in outside configuration.The protrusion 124 has linear edges 128 dimensioned and positioned tofit within the rectangular opening 140, as shown in FIG. 16. Roundedside portions 132 provide for rotation of the protrusion 124 within therectangular opening 140, as shown in FIG. 19. The closure 136 can beprovided within a tip portion 142 at a loop extension 148 and can bemanipulated to close the loop 152. A neck 144 of the tip 142 can beprovided to mate with the elongated shaft 118.

This invention can be embodied in other forms without departing from thespirit or essential attributes thereof and, accordingly, referenceshould be had to the following claims rather than the foregoingspecification as indicating the scope of the invention.

1. A surgical knot setter, comprising: an elongated shaft having a longaxis and proximal and distal portions; a tip at the distal portion ofsaid shaft, said tip having a loop with an interior loop opening and agate opening for permitting ingress and egress of a suture into the loopopening, said loop being laterally offset from the long axis of theshaft and distal to the distal end of the shaft, whereby the loop islaterally and longitudinally offset from the distal end of the shaft; aclosure for selectively opening and closing the gate opening betweenopen and closed positions to selectively permit or prevent said suturefrom passing through said gate opening; and, an actuator for moving saidclosure between said open and closed positions.
 2. The knot setter ofclaim 1, further comprising a handle at the proximal end of said shaft,a portion of said actuator being provided in said handle.
 3. The knotsetter of claim 1, wherein a portion of said actuator is aligned withthe loop and with the shaft.
 4. The knot setter of claim 1, wherein saidshaft is cylindrical.
 5. The knot setter of claim 1, wherein saidclosure is pivotally connected to said tip and operation of saidactuator causes pivoting of the closure between open and closedpositions.
 6. The knot setter of claim 1, wherein said closure ispivotally mounted to an exterior portion of said tip.
 7. The knot setterof claim 1, wherein the tip comprises an interior channel and theclosure is pivotally mounted within the channel.
 8. The knot setter ofclaim 1, wherein the tip comprises a guide surface for directing saidsuture into the gate opening.
 9. The knot setter of claim 8, where theguide surface extends from a side of the shaft to the loop.
 10. The knotsetter of claim 1, further comprising biasing for biasing the closure tothe closed position, a portion of the actuator operating against thebiasing to move the closure to the open position.
 11. (canceled) 12.(canceled)
 13. The knot setter of claim 1, wherein the actuatorautomatically returns the closure to the closed position when theactuator is not manipulated by a user.
 14. A method for tying knots withsutures, comprising the steps of: providing a surgical knot setter,comprising an elongated shaft having a long axis and proximal and distalportions; a tip at the distal end of the shaft, the tip having a loophaving an interior loop opening and a gate opening for permittingingress and egress of a suture into the loop opening, the loop beinglaterally offset from the long axis and distal to the distal end of saidshaft, whereby the loop is laterally and longitudinally offset from thedistal end of the shaft; a closure for selectively opening and closingthe gate opening between open and closed positions to selectively permitor prevent the suture from passing through the gate opening; and anactuator for moving the closure between the open and closed positions;positioning the actuator to cause the closure to move to the openposition; moving a suture through the gate opening into the interioropening of the loop; operating the actuator to cause the closure to moveto the closed position; tying the suture knot and moving the loop to setthe suture knot in position; operating the actuator to move the closureto the open position; and, removing the loop from the suture by passingthe suture through the gate opening.
 15. The method of claim 14, whereinthe closure is automatically maintained in the closed position untilacted upon by the actuator.
 16. The knot setter of claim 1, wherein theclosure moves toward the tip to open the gate opening, and moves awayfrom the tip to close the gate opening.
 17. The knot setter of claim 16,wherein the closure is mounted within a channel in the tip, the closuremoving into the channel to open the gate opening, and moving out of thechannel to close the gate opening.
 18. The method of claim 14, whereinthe closure moves toward the tip to open the gate opening, and movesaway from the tip to close the gate opening.
 19. The method of claim 18,wherein the closure is mounted within a channel in the tip, and theclosure moves into the channel to open the gate opening, and moves outof the channel to close the gate opening.